RIDASCREEN® Norovirus 3rd Generation C1401US

GUDID 04049095030079

The RIDASCREEN® Norovirus 3rd Generation EIA test is a qualitative enzyme immunoassay (EIA) intended for the detection of selected genogroup I (GI.1, GI.2, GI.3, GI.4, GI.7) and genogroup II (GII.1, GII.2, GII.3, GII.4, GII.5, GII.6, GII.7, GII.8, GII.10, GII.12, GII.13, GII.14, GII.17) norovirus strains in human feces as an aid in investigating the cause of acute gastroenteritis outbreaks.

R-Biopharm AG

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• Primary Device ID: 04049095030079
• NIH Device Record Key: 0c0fb252-ac39-4c74-a009-b9f3ce105fe4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIDASCREEN® Norovirus 3rd Generation
• Version Model Number: C1401US
• Catalog Number: C1401US
• Company DUNS: 321850323
• Company Name: R-Biopharm AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049095030079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN110001

FDA Product Code

• OUC: Norovirus Serological Reagent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-16
• Device Publish Date: 2019-05-08

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